Francesca Spera -

The Accelerating Clinical Trials in the EU (ACT EU) initiative has launched two pilot projects aimed at improving the quality of clinical trial authorization applications, which is crucial for the development of safe and effective medicines in Europe.

ACT EU is a collaboration between the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) of the Member States, and the European Commission (EC), aiming to transform how clinical trials are initiated, designed, and conducted.

The first pilot project focuses on providing integrated scientific advice, enabling multiple regulatory authorities to offer coordinated guidance to developers. This collaborative approach aims to streamline the drug development process, ensuring that new treatments reach patients more quickly and with enhanced safety.

The second pilot project aims to harmonize and simplify the clinical trial authorization process. By standardizing procedures and reducing administrative burdens, this initiative seeks to make Europe a more attractive destination for conducting high-quality clinical research.

Set to commence in the coming months, both projects emphasize collaboration, transparency, and the sharing of best practices. These initiatives represent a significant step toward creating a more unified and efficient regulatory environment for clinical studies in Europe.

 

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